Hyderabad Pharma Firm To Make Drug For Hard-To-Treat Bladder Cancer After Local Trials Waiver
Citing an 'unmet medical need" India's top drug advisory panel has approved a pharmaceutical firm's request to make and sell erdafitinib tablets in India by skipping a local third-phase trial but needing a post-launch fourth phase study.
Hyderabad-based Natco Pharma has presented the proposal for the grant of permission to manufacture and market erdafitinib in three different strengths along with the 'justification" for a waiver on local third-phase clinical trials, as per the minutes of the meeting of the technical committee dated July 17.
'After detailed deliberation, the committee opined that there is an unmet medical need for the proposed indication in the country," said the minutes, which were accessed by News18. 'The committee recommended for the grant of permission to manufacture and market the drug Erdafitinib Tablet 3 mg, 4 mg and 5 mg with local Phase III clinical trial waiver."
This marks a significant shift from the 2023 stance, when the subject expert committee (SEC), functioning under Central Drugs Standard Control Organisation (CDSCO), had rejected Natco's request for a Phase-III waiver. After reviewing the bioequivalence data, the SEC asked the company to 'submit the Phase-III clinical trial protocol before the committee for further consideration".
That earlier decision underscored the caution about approving cancer treatments without robust local safety and efficacy data.
According to the GLOBOCAN 2020 database, bladder cancer is the 17th most common malignancy in India. The five-year prevalence appears to be 3.57 per 1,00,000 population, leading to about 11,000 deaths each year.
The incidence of bladder cancer is higher in males as compared to females. Data shows that bladder cancer incidence does vary across India.
Among males, Delhi had the highest incidence rates followed by Thiruvananthapuram and Kolkata, and the lowest rate was in Dibrugarh. When it comes to females, the rate is highest in Delhi followed by Mumbai and Mizoram, respectively, and lowest in Barshi.
Over time, bladder cancer incidence has increased in Delhi, Bengaluru and Mumbai, while it has decreased in Chennai.
WHAT MAKES ERDAFITINIB IMPORTANT?
Erdafitinib is a targeted therapy that inhibits the fibroblast growth factor receptor (FGFR) – a key driver of rapid tumour growth in certain bladder cancers.
The FGFR gene gives the body instructions to make FGFR proteins, which sit on the surface of cells. These proteins receive growth signals (called fibroblast growth factors) and tell the cell when to grow, divide, or repair itself.
On January 19, 2024, the US FDA approved erdafitinib, sold under the brand name Balversa, developed by Janssen Biotech, a Johnson & Johnson company. The drug has been approved for adults with advanced or metastatic bladder cancer that has certain FGFR3 gene changes, confirmed by an approved test.
It can be used if the cancer has worsened after at least one previous systemic treatment. It is not meant for patients who could still benefit from PD-1 or PD-L1 immunotherapy and have not yet tried it.
ONCOLOGISTS WELCOME THE MOVE
According to the sellers on the online platform Indiamart, the bottle containing 56 tablets of 4mg Erdafitinib is sold at Rs 7,000, which is Rs 125 per tablet.
With local manufacturing, however, the cost is expected to drop by more than 50 per cent. 'It's a good drug for bladder cancer patients with locally advanced disease not responding to chemotherapy. This is targeted therapy that blocks fibroblast growth factor receptor (FGFR). This fibroblast growth factor helps cancer grow fast. This medicine blocks this growth and helps control cancer," said Dr Satya Prakash Yadav, director of paediatric haematology-oncology and bone marrow transplant at Medanta Hospital.
Similarly, Dr Pragya Shukla, who leads the clinical oncology department at Delhi State Cancer Institute, said the drug is for FGFR-altered metastatic urothelium, which has failed on multiple lines of chemotherapy and has shown benefits in overall survival in this particular group of patients.
As the panel cited 'unmet demand", Dr Shukla said: 'The drug should definitely benefit a particular group of patients waiting for a targeted therapy."
WHAT COMES NEXT?
If the technical committee's recommendation is adopted into a final CDSCO order, Natco Pharma may roll out erdafitinib across India – provided it submits a robust Phase-IV study protocol within three months of approval.
A fourth phase trial is the stage of research that happens after a drug has been approved by regulators and is already being sold in the market. It is also called post-marketing surveillance or post-approval study.
It can reveal safety issues, interactions, or benefits that did not appear in smaller or shorter trials before, and at times lead to changes in how the drug is prescribed – or even withdrawal if serious risks are found.
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